• Skip to main content
  • Skip to main content
Choose which site to search.
University of Arkansas for Medical Sciences Logo University of Arkansas for Medical Sciences
Research and Innovation: Institutional Review Board
  • UAMS Health
  • Jobs
  • Giving
  • About
    • Compliance Statement
    • Full Board Meetings
      • Committee Rosters
    • Institutional Review Board Blogs
    • Institutional Review Board Staff
    • Join the UAMS Institutional Review Board
    • Review Fees
  • CLARA
    • Access the System
    • Request a Human Subjects Research Determination
    • Start a Study
  • Templates, Training and Tools
    • Consent for Non-English Speakers
    • Events and Deviations Tables
    • Expanded Access Programs: Compassionate Use & Emergency Use
    • Human Subject Protection Training Instructions
  • Reporting to the Institutional Review Board
  • Expanded Access
  • Institutional Review Board Policies
    • Current Institutional Review Board Policies
      • 1 Principles and Authority
      • 2 Relationships
      • 3 Committee Membership
      • 4 Institutional Review Board Operations
      • 5 Records (Retired)
      • 6 Documentation
      • 7 Procedures for Study Review
      • 8 Change in Protocol
      • 9 Institutional Review Board Decisions
      • 10 Principal Investigator Responsibilities
      • 11 Appeals and Reconsiderations (retired)
      • 12 Quality Assurances
      • 13 Confidentiality
      • 14 Recruitment Practices
      • 15 Consent
      • 16 Risk / Benefit Analysis (moved)
      • 17 Special Populations
      • 18 Drugs and Devices
      • 19 Human Genetics Guidance
      • 20 Questions, Concerns, Suggestions and Complaints
    • Institutional Review Board Policy Archives
      • 1 Principles and Authority Archive
      • 2 Relationships Archive
      • 3 Committee Membership Archive
      • 4 Institutional Review Board Operations Archive
      • 5 Records Archive
      • 6 Documentation Archive
      • 7 Procedures for Study Review Archive
      • 8 Change in Protocol Archive
      • 9 Institutional Review Board Decisions Archive
      • 10 Principal Investigator Responsibilities Archive
      • 11 Appeals and Reconsiderations Archive
      • 12 Quality Assurances Archive
      • 13 Confidentiality Archive
      • 14 Recruitment Practices Archive
      • 15 Consent Archive
      • 16 Risk / Benefit Analysis Archive
      • 17 Special Populations Archive
      • 18 Drugs and Devices Archive
      • 19 Human Genetics Guidance Archive
      • 20 Questions, Concerns, Suggestions, Complaints Archive
  • Research Resources
    • Acronyms and Resources
    • FAQs
      • CITI Program FAQs
      • CLARA FAQs
      • Does my project need IRB review?
      • Prereview and Review Process FAQs
      • Reporting FAQs
      • Submission FAQs
    • Single / Central Institutional Review Board Review
  • Human Research Protection Program Plan
  1. University of Arkansas for Medical Sciences
  2. Research and Innovation
  3. Institutional Review Board
  4. New FDA guidance on electronic documents and signatures

New FDA guidance on electronic documents and signatures

The FDA has released a new guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations. The guidance provides information in a Q and A format about the FDA’s expectations for the use of electronic systems and records in research. The guidance also includes a section specific to electronic signatures in research. Do you know whether the FDA considers a signature drawn with a finger or stylus on a electronic system to be a handwritten signature and NOT an electronic signature? See question Q25 in the guidance to find out.

Posted by Edith Paal on October 2, 2024

Filed Under: Blog, Institutional Review Board Members, Research News

University of Arkansas for Medical Sciences LogoUniversity of Arkansas for Medical SciencesUniversity of Arkansas for Medical Sciences
Mailing Address: 4301 West Markham Street, Little Rock, AR 72205
Phone: (501) 686-7000
  • Facebook
  • X
  • Instagram
  • YouTube
  • LinkedIn
  • Pinterest
  • Disclaimer
  • Terms of Use
  • Privacy Statement
  • Legal Notices

© 2026 University of Arkansas for Medical Sciences